Investigation of PICOPREP and PEG-ELS for Bowel Preparation for Colonoscopy
Eligible subjects undergoing a colonoscopy will randomly receive either PICOPREP or polyethylene glycol 4000 electrolyte lavage solution before the procedure to evaluate its effectiveness, tolerability and safety.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Multi-center, Randomized, Single-blind Clinical Study of the Efficacy and Safety of PICOPREP and Polyethylene Glycol-electrolyte 4000 Powder for Oral Solution (PEG-ELS) for the Bowel Preparation Prior Colonoscopy|
- The Ottawa Scale Score of Patients Who Had Successfully Completed the Colonoscopy Examination After Having Completed the Study Bowel Preparation [ Time Frame: day 2 ] [ Designated as safety issue: No ]The total Ottawa Bowel Preparation Scale (OBPS) score, rated by the treatment-blinded Investigator at colonoscopy, was designed to evaluate cleanliness of the colon by grading the endoscopic visibility of the mucosa according to a scale from 0 ('excellent' visibility) to 4 ('inadequate' visibility); The component scores for each of the colon segment are added together, along with an overall 'fluid' score (from small amount = 0, to large amount = 2). Thus, the total OBPS has a range from 0 (a perfect preparation) to 14 (a completely unprepared bowel)
- Patient Response to Acceptability and Tolerability Questionnaire [ Time Frame: Day 2 ] [ Designated as safety issue: No ]On the day of the procedure, but before colonoscopy or any sedation for colonoscopy, subjects were asked to complete a standardised questionnaire regarding whether or not complete the IMP (yes or no), ease of taking IMP (rating from 1 point(very easy) to 5 point (very difficult)), degree of acceptability to study med (rating from 1 point (excellent) to 5 point (bad)), palatability of IMP (rating from 1 point (excellent) to 5 point (bad)) and tolerability (5 adverse reactions including abdominal bloating, spasms, nausea, vomiting and general malaise which were generally reported in bowel preparation with rating according to intensity from 1 point (None) to 4 point (Severe)).
- Ottawa Scale Score by Colon Segment [ Time Frame: Day 2 ] [ Designated as safety issue: No ]Mean Ottawa Scale scores, and score categories (from 'excellent' to 'bad'), are summarised by colon segment together with the overall fluid content score
- Percentage of Successful Completion of Colonoscopy [ Time Frame: Day 2 ] [ Designated as safety issue: No ]An overview of completion rates of colonoscopy (i.e., endoscope reaching the ileocecal valve)
- Proportion of Successful Colonoscopies in the Clinical Setting (Predicted by Ottawa Scale Score) [ Time Frame: Day 2 ] [ Designated as safety issue: No ]At colonoscopy, bowel preparations were rated by the treatment-blinded endoscopist, as being of an overall quality "adequate for clinical diagnostic purposes" (Y/N). The total Ottawa Scale scores was correlated with 'adequate' or 'inadequate' quality of bowel preparation for clinical diagnostic purposes
- Proportion of Subjects Requiring a Repeat Colonoscopy Due to Poor Bowel Preparation [ Time Frame: Day 2 ] [ Designated as safety issue: No ]The Proportion of subjects requiring a repeat colonoscopy due to poor bowel preparation
|Study Start Date:||January 2011|
|Study Completion Date:||July 2011|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
"Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy.
Active Comparator: PEG-ELS
PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination.
|The First Affiliated Hospital, Sun Yat-sen University|
|Nanfang Hospital, Southern Medical University|
|Drum Tower Hospital|
|Ruijin Hospital, Shanghai Jiaotong University School of Medicine|
|Renji Hospital, Shanghai Jiaotong University School of Medicine|
|Changhai Hospital, The Second Military Medical University|
|Huazhong Technological University Tongji Medical College Affiliated Union Hospital|
|Study Director:||Clinical Development Support||Ferring Pharmaceuticals|